MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Visual Impairment (2138)

Event Date 12/18/2016

Event Type  Injury  

Manufacturer Narrative

The flow diverter was not returned for analysis as it was implanted.The device was reported to have performed as intended as indicated by successful deployment of the device.There were no reports of any device deficiency during the placement.Vision impairment and ischemia are known inherent risk of endovascular procedure and are documented in the device's instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.The exact caused of the sluggish flow and vision impairment remains unknown but the patient as since recover.

Event Description

Medtronic received report that post successful flex deployment there was there was sluggish flow through the previously-patent ophthalmic artery.This event was treated infused of 2mg of integrilin and waited 15 minutes to perform another angio.Flow had improved in the ophthalmic artery.Another 2mg of integrilin was given, and the procedure was ended.The administration of integrilin was done because the physician felt that the patient¿s platelets may have become active and begun to aggregate.The pipeline did not inadvertently cover any perforator branch.No clot formations were seen in the scans.No vasospasms occurred during the procedure.One day post intervention, the patient had lost vision in the left eye.Another 6mg of integrilin was given iv.Ct was otherwise normal.Second day post intervention, the patient¿s visual loss has resolved, and the plan was to discharge the patient on the third day post intervention.

Manufacturer Narrative

Updated suspect medical device with the udi number.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irivne, CA 92618 ; 9492753836
• MDR Report Key: 6247935
• MDR Text Key: 64711749
• Report Number: 2029214-2017-00038
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: PED-400-16
• Device Lot Number: A263356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided; 12/19/2016
• Supplement Dates FDA Received: 01/13/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR